This role is hiring in Argentina only (Hybrid - 2 days per week in office in B.A.)
Please submit all CVs in English
Serves as Functional Lead for Clinical Data Science including primary contact for internal liaison between Clinical Data Science and Project Management, Clinical Monitoring, and other functional groups
Acts as central steward of clinical data quality, monitors risks through the holistic review of clinical and operational data, using high level knowledge of the protocol, taking into account the specific therapeutic area aspects of the protocol related to the data collected and aligning with cross functional operational plans to drive comprehensive clinical data quality
Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined study analysis
Works with assigned project teams to communicate, address, troubleshoot and resolve data related questions and recommends potential solutions; escalates issues which potentially impact patient safety and study analysis
Coordinates cross functional data cleaning activities to ensure quality standards and timelines are met for clinical data deliverables Ensures the required data elements and corresponding data quality oversight steps are identified to support the defined project analysis
Drives the development of the clinical data acquisition plan and corresponding data flow diagram with the study team, assess risks associated with protocol design, study set parameters that could impact the credibility and reliability of the trial results, aligns data flow with the study protocol to ensure data collected meets regulatory and study endpoint requirements.
Drives the development of analytical tools, utilizes analytical platform/dashboard to detect potentially unreliable data that may impact the validity of the trial results Performs analytic reviews as defined in scope of work and data acquisition plan, identifies root cause to systematically resolve data issues
Monitors and communicates project progress to the Sponsor and project team including use of project status reports and tracking tools/metrics
Ensures launch, delivery and completion of all Clinical Data Sciences activities and milestones according to contractual agreement and relevant Standard Operating Procedures (SOPs), guidelines, and regulations
Review, maintain budget and identify out of scope for Clinical Sciences activities, raise to PM to be implemented in required change order
Plans, manages, and requests Clinical Data Science resources for assigned projects
Coordinates the work of the assigned Clinical Data Science team
Develops and maintains project plans, specifications, and documentation in line with SOP requirements
Maintains documentation on an ongoing basis and ensures that all TMF filing is up to date for necessary files
Participates in, and presents at internal, Sponsor, third-party, and investigator meetings on behalf of clinical data science responsibilities
Prepares input, and participates in proposal bid defense meetings and request for proposals on behalf of clinical data science responsibilities
Plans for and creates necessary documentation to support internal and external audits; participates in such audits on behalf of clinical data sciences responsibilities
Trains and mentors new or junior team members
Maintains proficiency in Clinical Data Science systems and processes through regular training. May attend/represent the company at professional meetings/conferences
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%)
